Opioid Approval Standards Could Change Under New US FDA Plan
The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.
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FDA Opioid Review Adds Another Push For Advisory Committee Overhaul
External report on the US FDA’s response to the opioid epidemic includes detailed recommendations for enhancements to the advisory committee review process. That dovetails with the agency’s ongoing look at how best to use the expert panels.
‘Opioids’ Is Missing From The US FDA’s Overdose Prevention Framework Title On Purpose
Unlike prior plans, the FDA’s new substance abuse framework is intended to deal with stimulant and benzodiazepine use disorders, in addition to opioid abuse.
New Opioid Approval Standard Intended To Drive Development Into Other Therapeutics
US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.